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KYPROLIS Drug Profile

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Kyprolis is a drug marketed by Onyx Therap and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-nine patent family members in thirty-five countries.

The generic ingredient in KYPROLIS is carfilzomib. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.

Summary for Tradename: KYPROLIS

Patents:10
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list32
Clinical Trials: see list41
Patent Applications: see list91
Drug Prices:see details
DailyMed Link:KYPROLIS at DailyMed

Pharmacology for Tradename: KYPROLIS

Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Onyx Therap
KYPROLIS
carfilzomib
POWDER;INTRAVENOUS202714-001Jul 20, 2012RXYes► subscribe► subscribe
Onyx Therap
KYPROLIS
carfilzomib
POWDER;INTRAVENOUS202714-002Jun 3, 2016RXNo8,129,346► subscribe ► subscribe
Onyx Therap
KYPROLIS
carfilzomib
POWDER;INTRAVENOUS202714-001Jul 20, 2012RXYes8,129,346► subscribe ► subscribe
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Paragraph IV activity for: KYPROLIS

Drugname Dosage Strength RLD Submissiondate
carfilzomibFor Injection60 mg/vialKyprolis7/20/2016

Non-Orange Book Patents for Tradename: KYPROLIS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,198,270Compounds for proteasome enzyme inhibition► subscribe
8,088,741Compounds for enzyme inhibition► subscribe
8,207,124Compounds for enzyme inhibition► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: KYPROLIS

Country Document Number Estimated Expiration
Denmark1745064► subscribe
Japan5616569► subscribe
Hong Kong1103525► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: KYPROLIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90013-6Sweden► subscribePRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/15/1060 20151123
0160008 00189Estonia► subscribePRODUCT NAME: KARFILSOMIIB;REG NO/DATE: EU/1/15/1060 23.11.2015
C0017France► subscribePRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: EU/1/15/1060 20151123
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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